† GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.

‡ In an FDA-defined post hoc analysis, efficacy failure was defined as the occurrence of biopsy proven acute rejection (BPAR), graft loss, death, or lost to follow-up. BPAR was defined as histologically confirmed acute rejection by a central pathologist on a biopsy done for any reason, whether or not accompanied by clinical signs of rejection.

SELECTED IMPORTANT SAFETY INFORMATION

NULOJIX is associated with increased risk for post-transplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system (CNS)

NULOJIX is contraindicated in patients who are EBV seronegative or with unknown serostatus because the risk of PTLD is particularly increased in patients who are EBV seronegative

NULOJIX is to be used only in patients who are EBV seropositive

Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms

Higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressives is not recommended

Immunosuppression may result in increased susceptibility to infection and development of malignancies

NULOJIX should be prescribed only by physicians experienced in immunosuppressive therapy and management of kidney transplant patients

Use in liver transplant patients is not recommended due to an increased risk of graft loss and death

Management of Immunosuppression

Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX

Patients should be managed in facilities with adequate laboratory and supportive medical resources

The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient

Progressive Multifocal Leukoencephalopathy (PML)

NULOJIX patients are at increased risk for PML, often a rapidly progressive and fatal opportunistic infection

In clinical trials, two cases were reported in patients receiving NULOJIX at higher cumulative doses and more frequently than the recommended regimen, along with MMF and corticosteroids; one occurred in a kidney transplant recipient and one occurred in a liver transplant recipient

As PML has been associated with high levels of immunosuppression, higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressive agents, including MMF, are not recommended

Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms

If PML is diagnosed, consider reduction or withdrawal of immunosuppression, weighing risk to the graft

Other Malignancies and Serious Infections

Increased susceptibility to infection and possible development of malignancies may result from immunosuppression

Patients should avoid prolonged exposure to ultraviolet light and sunlight

Patients receiving immunosuppressants, including NULOJIX, are at increased risk for bacterial, viral, fungal, and protozoal infections, including opportunistic infections and tuberculosis. Some infections were fatal

Polyoma virus-associated nephropathy can lead to deteriorating renal function and graft loss; consider reduction in immunosuppression, weighing risk to the graft

Tuberculosis was more frequently observed in patients receiving NULOJIX. Evaluate for tuberculosis and initiate treatment for latent infection prior to NULOJIX use

CMV and Pneumocystis jiroveci prophylaxis is recommended after transplantation

Liver Transplant: use in liver transplant patients is not recommended due to increased risk of graft loss and death in a clinical trial with more frequent administration of NULOJIX than studied in kidney transplant, along with MMF and corticosteroids

Immunizations: avoid use of live vaccines during NULOJIX treatment

Coadministration with Anti-Thymocyte Globulin: in de novo kidney transplant recipients, especially those with other predisposing risk factors for venous thrombosis of the renal allograft, coadministration (at the same or nearly the same time) with anti-thymocyte globulin may pose a risk for venous thrombosis of the renal allograft. If anti-thymocyte globulin (or any other cell-depleting induction treatment) and NULOJIX will be administered concomitantly, a 12-hour interval between the two administrations is suggested

Acute Rejection and Graft Loss with Corticosteroid Minimization

In NULOJIX postmarketing experience, corticosteroid minimization to 5 mg/day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly Grade III

Corticosteroid utilization should be consistent with the NULOJIX clinical trial experience

Median (25th-75th percentile) corticosteroid doses were tapered to about 15 mg (10-20 mg)/day by the first 6 weeks and remained at about 10 mg (5-10 mg)/day for the first 6 months post-transplant

Pregnancy Category C: based on animal data, NULOJIX may cause fetal harm. NULOJIX should not be used in pregnancy unless potential benefit to the mother outweighs potential risk to the fetus. To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX, or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the
National Transplant Pregnancy Registry (NTPR) by calling 1-877-955-68771-877-955-6877

Expand

SELECTED IMPORTANT SAFETY INFORMATION

NULOJIX is associated with increased risk for post-transplant lymphoproliferative disorder (PTLD), predominantly in the central nervous system (CNS)

NULOJIX is contraindicated in patients who are EBV seronegative or with unknown serostatus because the risk of PTLD is particularly increased in patients who are EBV seronegative

NULOJIX is to be used only in patients who are EBV seropositive

Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms

Higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressives is not recommended

Immunosuppression may result in increased susceptibility to infection and development of malignancies

NULOJIX should be prescribed only by physicians experienced in immunosuppressive therapy and management of kidney transplant patients

Use in liver transplant patients is not recommended due to an increased risk of graft loss and death

IMPORTANT SAFETY INFORMATION

Post-Transplant Lymphoproliferative Disorder (PTLD)

NULOJIX patients are at increased risk for developing PTLD, predominantly involving the central nervous system (CNS)

Recipients without immunity to EBV (ie, seronegative) are at particularly increased risk; therefore, NULOJIX is contraindicated in transplant recipients who are EBV seronegative or with unknown serostatus

Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms

As the total burden of immunosuppression is a risk factor for PTLD, higher than recommended doses or more frequent dosing of NULOJIX or concomitant immunosuppressive agents are not recommended

Other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy

CMV prophylaxis is recommended for at least 3 months after transplantation

Use T-cell-depleting therapy to treat acute rejection cautiously

Patients who are EBV seropositive and CMV seronegative may be at increased risk of PTLD

Since CMV seronegative patients are at increased risk for CMV disease (a known risk factor for PTLD), the clinical significance of CMV serology for PTLD remains to be determined; however, these findings should be considered when prescribing NULOJIX

Management of Immunosuppression

Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX

Patients should be managed in facilities with adequate laboratory and supportive medical resources

The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient

Progressive Multifocal Leukoencephalopathy (PML)

NULOJIX patients are at increased risk for PML, often a rapidly progressive and fatal opportunistic infection

In clinical trials, two cases were reported in patients receiving NULOJIX at higher cumulative doses and more frequently than the recommended regimen, along with MMF and corticosteroids; one occurred in a kidney transplant recipient and one occurred in a liver transplant recipient

As PML has been associated with high levels of immunosuppression, higher than recommended doses or more frequent dosing of NULOJIX and concomitant immunosuppressive agents, including MMF, are not recommended

Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms

If PML is diagnosed, consider reduction or withdrawal of immunosuppression, weighing risk to the graft

Other Malignancies and Serious Infections

Increased susceptibility to infection and possible development of malignancies may result from immunosuppression

Patients should avoid prolonged exposure to ultraviolet light and sunlight

Patients receiving immunosuppressants, including NULOJIX, are at increased risk for bacterial, viral, fungal, and protozoal infections, including opportunistic infections and tuberculosis. Some infections were fatal

Polyoma virus-associated nephropathy can lead to deteriorating renal function and graft loss; consider reduction in immunosuppression, weighing risk to the graft

Tuberculosis was more frequently observed in patients receiving NULOJIX. Evaluate for tuberculosis and initiate treatment for latent infection prior to NULOJIX use

CMV and Pneumocystis jiroveci prophylaxis is recommended after transplantation

Liver Transplant: use in liver transplant patients is not recommended due to increased risk of graft loss and death in a clinical trial with more frequent administration of NULOJIX than studied in kidney transplant, along with MMF and corticosteroids

Acute Rejection and Graft Loss with Corticosteroid Minimization

In NULOJIX postmarketing experience, corticosteroid minimization to 5 mg/day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly Grade III

Corticosteroid utilization should be consistent with the NULOJIX clinical trial experience

Median (25th-75th percentile) corticosteroid doses were tapered to about 15 mg (10-20 mg)/day by the first 6 weeks and remained at about
10 mg (5-10 mg)/day for the first 6 months post-transplant

Immunizations: avoid use of live vaccines during NULOJIX treatment

Coadministration with Anti-Thymocyte Globulin: in de novo kidney transplant recipients, especially those with other predisposing risk factors for venous thrombosis of the renal allograft, coadministration (at the same or nearly the same time) with anti-thymocyte globulin may pose a risk for venous thrombosis of the renal allograft. If anti-thymocyte globulin (or any other cell-depleting induction treatment) and NULOJIX will be administered concomitantly, a 12-hour interval between the two administrations is suggested

Pregnancy Category C: based on animal data, NULOJIX may cause fetal harm. NULOJIX should not be used in pregnancy unless potential benefit to the mother outweighs potential risk to the fetus. To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX, or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the
National Transplant Pregnancy Registry (NTPR) by calling 1-877-955-68771-877-955-6877

Nursing Mothers: discontinue NULOJIX or nursing, considering importance of NULOJIX to the mother

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